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The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.

The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.

The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.

In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.

The compression massage direction is from foot room and push up the thighs. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.

The provided text, a 510(k) Premarket Notification from the FDA, describes an "Air Compression Therapy Device, model: ST-502". This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K193354).

It does not contain information related to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML-driven medical device. The device described is a physical medical device (a powered inflatable tube massager) and the evaluation is for substantial equivalence to a predicate, not performance against specific AI/ML metrics.

Therefore, I cannot provide the requested information about acceptance criteria and a study report as it pertains to an AI/ML device per your prompt, because the provided input does not describe such a device or study.

If the prompt was intended to ask about the non-AI/ML device described in the document, here's what can be inferred about its "acceptance criteria" and "proof" based on the provided FDA submission:

Interpretation for the provided Non-AI/ML Device (Air Compression Therapy Device):

For this type of device, "acceptance criteria" would primarily revolve around demonstrating performance and safety characteristics similar to the predicate device, as well as adherence to recognized consensus standards. The "study that proves the device meets the acceptance criteria" would be the collection of non-clinical tests and comparisons performed.

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way an AI/ML study would specify metrics and results. Instead, it demonstrates substantial equivalence by comparing technical characteristics and compliance with standards. The "acceptance" is implied by demonstrating equivalence to a legally marketed device and meeting safety and performance standards.

Here's an inferred table based on the comparisons made:

2. Sample size used for the test set and the data provenance:

• This is not applicable in the context of an AI/ML test set.
• For this physical device, the "test set" would implicitly refer to the physical units subjected to the non-clinical tests (e.g., electrical safety, EMC, biocompatibility). The document does not specify the number of units tested, which is typical for such submissions where testing is generally done on representative samples.
• Data provenance is not specified, but these are typically lab-based non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable for this device as it's not an AI/ML device requiring expert ground truth for classification/detection.
• The "truth" for this device is based on objective measurements against engineering and safety standards (e.g., measuring pressure output, electrical leakage, electromagnetic emissions, and biological reactions in lab tests).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as there is no human-in-the-loop assessment or subjective interpretation being adjudicated. The tests are objective measurements against specified standard limits.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a physical therapy device, not an AI/ML diagnostic or assistive tool. No human reader studies were conducted or are relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm-only device. The core functionality is mechanical (pneumatic compression).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For this device, the "ground truth" for its safety and performance is established through compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and direct physical/mechanical measurements (e.g., pressure output, timing accuracy, noise level). There is no "pathology" or "outcomes data" ground truth in the sense of a medical diagnostic AI.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established:

• Not applicable. As there's no training set for an AI/ML model.

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The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Therapy Device, model HW6007

The provided text is an FDA 510(k) clearance letter for an Air Compression Therapy Device (model HW6007). This document does not contain information about acceptance criteria, study details, or device performance metrics.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Outlines regulatory requirements the manufacturer must comply with (registration, labeling, good manufacturing practices, etc.).
• Specifies the indications for use of the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on this document. These details are typically found in the 510(k) summary or the full submission, which are not included here.

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The Air Compression Therapy Device are indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

The provided text is an FDA 510(k) clearance letter for an Air Compression Therapy Device. It confirms substantial equivalence to a predicate device and states the indications for use. However, it does not contain the detailed information necessary to answer your specific questions about acceptance criteria for device performance, the study that proves it meets those criteria, or the methodology of such a study.

The letter focuses on regulatory clearance based on substantial equivalence, and while it references labeling and good manufacturing practices, it doesn't describe the clinical or performance studies you're asking about. Such information would typically be found in the manufacturer's 510(k) submission summary or other technical documentation, not in the FDA's clearance letter itself.

Therefore, I cannot provide the requested information from the given input.

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The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

This document is a 510(k) premarket notification for an "Air Compression Therapy Device," which is a powered inflatable tube massager. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, focusing on non-clinical testing. This document does NOT describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, I cannot provide a response that directly addresses the prompt's request for information on acceptance criteria and study proving an AI device's performance, including details like:

• Sample size for the test set and data provenance: The document mentions "non-clinical tests" and "safety and performance tests" but does not detail a test set of patient data.
• Number of experts and qualifications for ground truth: Not applicable for non-clinical device testing.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Explicitly stated "No clinical test data was used to support the decision of substantial equivalence."
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: Not applicable for non-clinical testing.
• Sample size for the training set: Not applicable as there is no AI/ML component.
• How ground truth for the training set was established: Not applicable.

However, I can extract the acceptance criteria and performance related to the mechanical and electrical safety and manufacturing aspects of this non-AI medical device based on the provided text.

Acceptance Criteria and Device Performance for Shenzhen Dongjilian Electronics Co., Ltd.'s Air Compression Therapy Device (K193354)

The provided submission primarily relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety, performance, and adherence to recognized standards. It does not present clinical study data or involve AI/Machine Learning technologies for diagnostic or prognostic purposes, nor does it involve human readers or ground truth established by expert consensus on clinical cases.

The "acceptance criteria" in this context refer to the device conforming to safety and performance standards for its type.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of patient data or clinical cases because no clinical testing was performed. The tests conducted were non-clinical, focusing on the device's physical, electrical, software, and material properties. The data provenance is implied to be from Shenzhen Dongjilian Electronics Co., Ltd.'s internal testing, as it's part of their 510(k) submission. No information on country of origin of patient data (retrospective or prospective) is applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth, in the context of this submission, refers to the device's conformance to recognized engineering and safety standards, not clinical diagnostic accuracy based on expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical air compression therapy device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is its conformance to established international and national consensus standards for medical device safety, electromagnetic compatibility, usability, software, biocompatibility, and risk management, along with internal enterprise standards for performance. This is not a clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient cases).

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no AI/ML model or training set.

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